Baseline – median
viral load and CD4 in the APV arm were 44,000 copies/ml and 442 in the APV +
AZT/3TC arm.

Viral Load Results:

At week 48, 93% (n=54)
had <400 copies/ml using the As-Treated analysis which is less stringent
than the ITT analysis.

Using the ITT (n=116)
where discontinuations are considered failures 42% had <400 copies/ml.

CD4s increased about
199 from baseline to week 48.

APV
Viral Load Changes By Baseline Viral Load (See
Table 15):

Table 15.

Baseline
Viral Load

As
Treated Analysis <400

<400
ITT

10,000–
30,000

87%
(20/23)

51%
(19/37)

30,000-100,000

24/24
(100%)

42%
(23/55)

>100,000

86%
(6/7)

25%
(6/24)

Investigators reported
an ITT Observed Data analysis (<50 copies/ml) which is not as stringent as an
ITT analysis but also not as liberal as an as-treated analysis. At week 16, 59%
had <50 copies/ml (n=88).At
week 48 they reported 69% had <50 copies but this included individuals who
switched to APV after week 16 because their viral load was >400 copies/ml.

Lipids
and Lipodystrophy.They reported there were no grade 3 or 4 elevations in triglycerides or
cholesterol (n=113) and 1 person had hyperglycemia. One case of abnormal fat
redistribution has been reported to date. The subject received over 1 year of
APV and remains in study with undetectable VL.Because the study population is treatment-naïve they might be less prone
to develop lipodystrophy and one year may not be enough time for lipodystrophy
to develop.